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The Impact of Bariatric Surgery Induced Weight Loss on Lung Function in Adolescents

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Patrick Stafler, Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Patrick Stafler, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT02644174
First received: December 30, 2015
Last updated: April 11, 2017
Last verified: April 2017
  Purpose
In this prospective study we will evaluate the changes in respiratory physiology occurring in morbidly obese adolescents following bariatric surgery at Schneider Children's Medical Center of Israel (SCMCI).

Condition Intervention
Obesity Procedure: Bariatric Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Bariatric Surgery Induced Weight Loss on Lung Function in Adolescents

Resource links provided by NLM:


Further study details as provided by Patrick Stafler, Rabin Medical Center:

Primary Outcome Measures:
  • Change from Baseline Lung Clearance Index [ Time Frame: 3 months post op ]

Secondary Outcome Measures:
  • Change from Baseline High sensitivity C reactive protein [ Time Frame: 3 months post op ]

Estimated Enrollment: 60
Study Start Date: May 2016
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Detailed Description:

Morbid obesity leads to restrictive as well as obstructive ventilatory defects via mechanisms that include mechanical, as well as inflammatory factors. We hypothesise that multiple breath nitrogen washout will be more sensitive to changes in small airway function than conventional lung function testing.

We will invite adolescents with morbid obesity, scheduled to undergo bariatric surgery at SCMCI during 2016-2018, for pulmonary function testing, including spirometry, plethysmography, nitrogen multiple breath washout, lung transfer factor and 6 minute walk. These tests will be conducted prior to the operation as well as during follow-up appointments at 3, 6 and 12 months. We will also evaluate oxidative stress using highly sensitive C-reactive protein as surrogate marker.

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adolescents with morbid obesity who will undergo bariatric surgery
Criteria

Inclusion Criteria:

  • Adolescents with morbid obesity who will undergo bariatric surgery at the paediatric surgery ward of Schneider Children's Medical Center during 2016-2018

Exclusion Criteria:

  • Adolescents with background diseases which might influence their ability to conduct pulmonary function tests (for example, patients with neurological disorders)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02644174

Contacts
Contact: Patrick Stafler, MD 972-54-7243623 pstafler@hotmail.com

Locations
Israel
Schneider Children's Medical Center of Israel Recruiting
Petach Tikva, Israel, 49202
Contact: Patrick Stafler, MD    972547243623    pstafler@hotmail.com   
Sponsors and Collaborators
Rabin Medical Center
  More Information

Publications:

Responsible Party: Patrick Stafler, Dr, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02644174     History of Changes
Other Study ID Numbers: 0126-16-RMC
Study First Received: December 30, 2015
Last Updated: April 11, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Peer reviewed journal

Keywords provided by Patrick Stafler, Rabin Medical Center:
Obesity
Lung function test
Bariatric surgery

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2017